Atlas FDA

ARCHITECT ICARBAMAZEPINE ICARBAMAZEPINE REAGENTS; ARCHITECT ICARBAMAZEPINE CALIBRATORS

FDA 510(k) clearance K103627 · decided 2011-10-14

Clearance details

K-number
K103627
Device name
ARCHITECT ICARBAMAZEPINE ICARBAMAZEPINE REAGENTS; ARCHITECT ICARBAMAZEPINE CALIBRATORS
Applicant
Abbott Laboratories
Decision
Substantially Equivalent
Date received
2010-12-13
Decision date
2011-10-14
Days to decision
305 days
Clearance type
Traditional
Product code
KLT
Device class
2
Regulation number
862.3645
Medical specialty
Clinical Toxicology
Advisory committee
Clinical Toxicology
Location
Abbott Park, IL, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
Carbamazepine Gen 4 (K151578)Roche Diagnostics Operations (Rdo)2015-10-22
ABBOTT CARBAMAZEPINE ASSAY (K123518)Microgenics Corporation2013-06-05
CARBAMAZEPINE, VALPROIC ACID, TDM CALIBRATION SET B AND ABTROL, NORTROL CONTROLS (K063131)Thermo Electron OY2007-10-05
ADVIA IMS CARBAMAZEPINE METHOD (K042808)Bayer Healthcare, LLC2005-02-08
ONLINE TDM CARBAMAZEPINE (K031902)Roche Diagnostics Corp.2003-09-17
RANDOX CARBAMAZEPINE (K011648)Randox Laboratories, Ltd.2002-01-15
EMIT 2000 CARBAMAZEPINE ASSAY, MODEL OSR4F229 (K010814)Syva Co., Dade Behring, Inc.2001-04-13
ADDITIONAL ASSAYS FOR BAYER ADVIA IMS SYSTEM (K000903)Bayer Corp.2000-05-18
IMMULITE CARBAMAZEPINE, IMMULITE 2000 CARBAMAZEPINE, CATALOG # LKCB1, LKCB5 & L2KCB2, L2KCB6 (K000007)Diagnostic Products Corp.2000-02-28
SYVA EMIT II PLUS BARBITURATE ASSAY, MODEL 9D029UL/9D129UL (K993987)Syva Co.2000-01-27
ABBOTT AEROSET CARBAMAZEPINE ASSAY AND CALIBRATORS; MODELS 1E12 AND 6E90 (K993028)Syva Co.2000-01-27
VITROS CHEMISTRY PRODUCTS CRBM SLIDES (K980283)Johnson & Johnson Clinical Diagnostics, Inc.1998-02-25

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
ARCHITECT AFP; Alinity i AFP (LN 3P36/07P90) (P120008/S032)Abbott Laboratories2026-05-11
ARCHITECT Total PSA / Alinity i Total PSA (LN 6C06/07P92) (P910007/S068)Abbott Laboratories2026-02-23
ARCHITECT Free PSA; Alinity i Free PSA (LN 6C07/07P93) (P980007/S056)Abbott Laboratories2026-02-12
ARCHITECT Total PSA; Alinity i Total PSA (LN 6C06/07P92) (P910007/S067)Abbott Laboratories2026-02-12
ARCHITECT AFP; Alinity i AFP (LN 3P36/07P90) (P120008/S031)Abbott Laboratories2026-02-12
ARCHITECT CORE / Alinity i Anti-HBc (P080023/S046)Abbott Laboratories2025-04-03
ARCHITECT AFP / Alinity i AFP (P120008/S030)Abbott Laboratories2025-04-03
ARCHITECT CORE-M / Alinity i Anti-HBc IgM (P060035/S043)Abbott Laboratories2025-04-03